Identification of Early Predictive Factors of Cardiac and Cerebral Involvement in Thrombotic Microangiopathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- 30-day event-free survival
研究概览
简要总结
The aim of this study is to determine the frequency of cardiac and cerebral involvements in patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy at the acute phase.
The primary outcome measurement is the event free survival at day 30, as defined by death, myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three daily analyses performed after TMA diagnosis.
详细描述
After TMA diagnosis, patients will be treated in emergency according to standard National recommendations. Patient will be included in the study as soon as the diagnosis of TMA is performed.
From day 1 to day 3, specific blood tests will be performed (serum troponin Ic and brain natriuretic peptide [BNP]). A cardiac ultrasonography within the 4 first days and a cerebral MRI within the first 7 days after TMA diagnosis will be performed.
Our hypothesis is that an increased serum troponin Ic level on diagnosis (> 0.2 ng/ml) is a predictive feature of cardiac events or worsening at the acute phase.
At 6 months, a control cardiac ultrasonography and cerebral MRI will be performed in patients with cardiac and/or cerebral involvement on diagnosis.
122 patients are expected to be included among 30 recruiting centres in France. The total duration of inclusions is 2.5 years, and the total duration of the study is of 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of thrombotic microangiopathy on the following criteria :
- •A microangiopathic haemolytic anaemia (Hb< 12 g/dl, with presence of schistocytes on blood smear);
- •A thrombocytopenia <150 G/l;
- •No associated (precipitating) disease (HIV infection, cancer, chemotherapy, transplantation) or pregnancy;
- •A written consent obtained from the patient, or from a relative for patients unable to provide the informed consent (because of cerebral involvement for example);
- •Affiliation at the social insurance regimen.
- •Major person
排除标准
- •A TMA associated with an associated condition: infection with HIV (HIV) in AIDS stage, , chemotherapy, malignancy, transplantation, or pregnancy.
研究组 & 干预措施
Biological investigations
From day 1 to day 3, specific blood tests will be performed (serum troponin Ic and brain natriuretic peptide [BNP]). A cardiac ultrasonography within the 4 first days and a cerebral MRI within the first 7 days after TMA diagnosis will be performed.
干预措施: Biological and imaging investigations (Other)
结局指标
主要结局
30-day event-free survival
时间窗: At 30 days
Events include death or myocardial infarction, arrhythmia, cerebral involvement and exacerbation. Serum troponin Ic is assessed daily the 3 first days following diagnosis. Cardiac ultrasonography is performed within the 4 days following diagnosis and cerebral MRI is performed within the 7 days following the diagnosis.
次要结局
- Cardiac trouble frequency and type at diagnosis(From day 1 to day 3 after diagnosis)
- Cerebral trouble frequency and type at diagnosis(From day 1 and day 7 after diagnosis)
- Comparison of cerebral and cardiac trouble at diagnosis between thrombotic microangiopathies type(Baseline)
- Description of cardiac and cerebral sequelae at M6 and reversibility frequency of diagnosis cardiac and cerebral lesions at M6(At 6 months)
- Determination of cardiac and cerebral sequelae prognostic factors at M6(At 6 months)